GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Any commercially available NSAID with the indication for osteoarthritis; Drug: Celecoxib

• Registration Number: NCT00373685
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Study Start: 2006-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-10-26
• Results First Submitted QC: 2011-10-26
• Results First Posted: 2011-11-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8067

Inclusion Criteria

• Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria

• GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
• Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAIDs	Any commercially available NSAID with the indication for osteoarthritis	-
Celecoxib	Celecoxib	dosing as per USPI label

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)	Baseline through week 24 or Early Termination (ET)	CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)	Baseline through week 24 or ET	GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions
Hemoglobin (Hb) at Baseline	Baseline
Percentage of Participants With Moderate to Severe Abdominal Symptoms	Baseline through week 24 or ET	Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.
Change From Baseline Hb at Week 24	Baseline and Week 24 or ET
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief	Baseline, Weeks 8, 16, 24 or ET	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.
Hematocrit (Hct) at Baseline	Baseline
Change From Baseline Hct at Week 24	Baseline and Week 24 or ET
Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline	Baseline, Weeks 8, 16, 24 or ET	Clinically significant decrease in Hct (greater than or equal to 10 percent \[≥10%\]) and/or decrease in Hb (≥ 2 g/dL).
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief	Baseline, Weeks 8, 16, 24 or ET	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.
Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall	Baseline, Weeks 8, 16, 24 or ET	Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief	Baseline, Weeks 8, 16, 24 or ET	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Trujillo Alto, Puerto Rico